(227 days)
Luvena Vaginal Moisturizer and Lubricant is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms.
Luvena Vaginal Moisturizer & Lubricant is non-sterile, translucent, non-staining, non-greasy, aqueous-based, cranberry-flavored gel and is packed in EVA/PE copolymer plastic applicator tube. Each application tube is single-use. It is for personal vaginal use as need for moisturizing and lubrication during intimate sexual activity. This device is not a contraceptive or spermicide, nor does it contain any such component. It is compatible with natural rubber latex and polyisoprene condoms, but is not compatible with polyurethane condoms as demonstrated in condom compatibility testing conducted according to ASTM D7661-10.
This document is a 510(k) Summary for the Luvena Vaginal Moisturizer & Lubricant (K162235). The primary purpose of this summary is to demonstrate substantial equivalence to a predicate device, not to provide a detailed study for meeting specific acceptance criteria in the context of an AI/algorithm-based medical device. Therefore, much of the requested information regarding AI device evaluation is not directly available in this text.
However, I can extract information related to the device's specifications and the testing performed to ensure its safety and effectiveness, which can be interpreted as fulfilling certain acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a personal lubricant, the "acceptance criteria" are related to its physical properties, microbial safety, biocompatibility, and compatibility with condoms.
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Physical Properties | Appearance, Odor, pH, Viscosity, Osmolality | Appearance: non-sterile, translucent, non-staining, non-greasy |
| Odor: Cranberry-flavored gel | ||
| pH: 3.8 - 4.8 (Matches predicate) | ||
| Viscosity, Osmolality: Evaluated (Specific values not provided, but implicitly met specifications) | ||
| Microbiological Safety | Total Aerobic Microbial Count (TAMC) (USP and ) | |
| Total Yeast and Mold Count (TYMC) (USP and ) | ||
| Absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans (USP )) | Met specifications as recommended in USP for vaginal use products. Also passed Antimicrobial Preservative Effectiveness Validation testing under USP Category 2. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | |
| Sensitization (ISO 10993-10:2010 - GPMT) | ||
| Vaginal Irritation (ISO 10993-10:2010) | ||
| Acute Systemic Toxicity (ISO 10993-11:2006) | The results demonstrate that the subject lubricant is biocompatible. | |
| Condom Compatibility | Compatibility with natural rubber latex and polyisoprene condoms | |
| Incompatibility with polyurethane condoms (ASTM D7661-10) | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. (Matches predicate and tested per ASTM D7661-10) | |
| Shelf Life | Stability testing (ICH-Q1A, ICH-Q1E) | Results of accelerated time testing and real-time testing support the proposed shelf life. (Specific shelf life duration not provided but implied as adequate). |
2. Sample Size for Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/algorithm evaluation. The testing described falls under laboratory and in vitro testing for a physical product (lubricant). Therefore, information on "country of origin of data" or "retrospective/prospective" does not apply in the typical sense for AI devices. The sample sizes for the various physical, chemical, and biological tests performed on the lubricant formulation are not specified in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. "Experts" in this context would be laboratory technicians and chemists performing the tests according to established standards (ISO, USP, ASTM). There isn't a "ground truth" to be established by human experts in the way it would be for an AI device.
4. Adjudication Method
Not applicable, as there is no "adjudication" in the context of expert review for an AI device. The tests are laboratory-based and yield objective results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device, so there is no comparison of human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is a physical device (lubricant), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" in this context is established by:
- Established standards: ISO, USP, and ASTM test methods define the benchmarks against which the lubricant's properties (biocompatibility, microbial limits, condom compatibility) are measured.
- Laboratory measurements: Objective physical, chemical, and biological assays directly determine the characteristics of the product.
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/algorithm device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.